The present invention relates to dispensing devices for administration of drug dosage forms and systems comprising them. The invention further includes a dispensing device that provides a means for detecting the identity of the patient, a lock-out feature and a means to prevent unauthorized access to stored drugs.
Currently, standard medical devices for repeated therapeutic administration of drugs in both the in-patient and out-patient setting including routes of administration, formulations and dosage control have clear limitations with regard to both efficacy and toxicity.
Controlled drug delivery and dispensing technology represents an area of active research and controlled drug delivery systems offer numerous advantages as compared to current drug delivery systems, which include improved safety, improved patient compliance and convenience.
U.S. Patent Publication No. 20050054942 discloses systems and methods for monitoring therapeutic drug concentration in the blood by detecting markers, upon exhalation by a patient after the drug is taken, using electronic sensor technology and a reporting system.
U.S. Pat. No. 6,824,512 discloses a closed loop system for monitoring drug dose, intake and effectiveness which includes a pill dispenser in data communications with at least one implantable medical device. The system includes high speed computers and databases relating to patient history and device information.
U.S. Pat. No. 6,190,326 discloses a system for collecting patient respiratory information which includes a base unit and a removable mouthpiece.
U.S. Pat. No. 6,039,251 discloses a method and system for controlling an in home medical device, such as a drug delivery pump, wherein a control program or “prescription” for control of the device is encoded on a portable card. Data relating to the device can be saved to the card, and a security program is provided which ensures that only authorized patients can use the medical device. Remote access to the medical device is provided through a communication system between the controller for the medical device and a remotely located computer.
U.S. Pat. No. 5,752,620 discloses a pill dispenser, comprising a container constructed to hold a plurality of pills, with a pill release mechanism provided to dislodge the pill from the pill holder by pneumatic pressure and sensors located on the exit port to detect the presence of a dispensed pill, which is recorded by an attached computer. Optionally, a locking device is attached to the pill dispensing units to prevent unauthorized dispensation of medication.
U.S. Pat. No. 5,710,551 discloses a system for the remote monitoring of in home self-medication to assure compliance with prescribed dosage schedules.
U.S. Pat. No. 5,945,651 discloses a medication dispensing system including a relatively small, microprocessor-controlled machine that assists in the accurate execution of a physician-prescribed medication regimen. The machine can be used as a stand-alone unit, or can be integrated into a centrally-controlled pharmaceutical network.
U.S. Pat. No. 5,995,938 discloses a medication compliance system having an output device and a computer in communication with the output device for use in printing a label.
The relevant art does not describe a dispensing device that does not require the opening and closing of a lid or other hinged aperture for delivery of drug dosage forms.
Although currently available drug dispensing devices have been effective in the administration of a variety of types of drugs, there remains a need for improved devices for self-administration of drugs that provide for safe and controlled access. There is a further need for drug delivery device which provides for improved safety and ease of use including, for example: a security feature that would prevent unauthorized access to the stored drugs, a lock-out feature to deter overdosing, a dose counting feature, a memory means for retaining information about dose delivery, a theft deterrent feature to theft in hospital, and an interface for exchanging information with another device such as a computer.
There is, therefore, substantial interest in the development of improved devices and systems, for drug delivery, for example for the treatment of acute, intermittent and breakthrough pain, in both the hospital and out-patient settings.